野战(应急)快速检验系统生化分析模块性能的综合评价  

Performance evaluation on biochemistry analysis module of biochem POCT solutions

作　　者：王缚鲲[1] 李玮[1] 王宪灵[1] 安黎云[1] 汤菲[1] 贺政新[1] 时兰春[2] 霍江涛[2] 

机构地区：[1]解放军白求恩国际和平医院检验实验科,河北石家庄050082 [2]解放军白求恩医务士官学校生化教研室,河北石家庄050082

出　　处：《中国医学装备》2014年第2期81-83,共3页China Medical Equipment

摘　　要：目的:对北京倍肯公司研发的野战(应急)快速检验系统生化分析模块(SP4430)基本性能进行综合评价。方法:对野战(应急)快速检验系统生化分析模块分别在室内环境与模拟野战环境下进行精密度评价,并对其在两种不同环境下的检测结果进行对比;对野战(应急)快速检验系统生化分析模块与日本OLYMPUS AU5421全自动生化分析仪所测定结果进行比较,分析二者之间有无差异。结果:生化分析模块GLU、UA、ALB、REA、ALT、TBIL、LDH、AMS在室内的CV(%)分别为2.08、2.89、1.56、2.38、4.10、2.36、3.19、6.33;在模拟野战环境下的CV(%)分别为2.31、3.12、2.11、2.32、4.80、2.57、4.51、7.14;GLU(mmol/L)、UA(umol/L)、ALB(g/L)、CREA(umol/L)、ALT(U/L)、TBIL(umol/L)、LDH(U/L)、AMS(U/L)在室内结果分别为5.91±2.03、269.50±111.50、35.89±7.55、94.08±22.150、42.71±27.62、10.30±5.75、173.60±59.99、67.45±25.06,在模拟野战环境下的结果分别为6.33±2.31、273.38±120.56、34.90±6.99、94.85±23.15、37.73±24.64、10.18±5.71、170.43±61.74、68.02±25.14;所有项目室内与模拟野战环境的检测结果采用配对t检验比较,P值均>0.05;结果表明生化分析模块与OLYMPUS AU5421所测GLU、UA、ALB结果差异无统计学意义(P>0.05),而CREA、ALT、TBIL、LDH、AMS所测结果差异有统计学意义(P<0.01)。两种仪器所有检测结果的相关系数均>0.90。结论:在室内、模拟野战环境下,野战(应急)快速检验系统生化分析模块精密度良好,结果比较无显著差异;生化分析模块与实验室常规生化分析仪检测结果相关性良好,由于检测方法不同,部分结果差异较大,但仍然具有可比性。Objective： To evaluate the performance of biochemistry analysis module of Biochem POCT Solutions. Methods：The precision of the biochemistry analysis module of Biochem POCT Solutions was estimated indoor and in simulated field environment, and then compared the results. Fresh blood samples of 200 patients were detected with the biochemistry analysis module and OLYMPUS AU5421 automatic biochemical analyzer respectively, and the results were compared. Results：GLU, UA, ALB, CREA, ALT, TBIL, LDH and AMS variation coefficients （CVs） were 2.08%, 2.89%, 1.56%, 2.38%, 4.10%, 2.36%, 3.19%and 6.33%indoor, and in simulated field environment CVs were 2.31%, 3.12%, 2.11%, 2.32%, 4.80%, 2.57%, 4.51%and 7.14%. GLU（mmol/L）, UA（umol/L）, ALB（g/L）, CREA（umol/L）, ALT（U/L）, TBIL（umol/L）, LDH（U/L） and AMS（U/L） were 5.91＆#177;2.03, 269.50＆#177;111.50, 35.89＆#177;7.55, 94.08＆#177;22.150, 42.71＆#177;27.62, 10.30＆#177;5.75, 173.60＆#177;59.99 and 67.45＆#177;25.06 indoor, and results in simulated field environment were 6.33＆#177;2.31, 273.38＆#177;120.56, 34.90＆#177;6.99, 94.85＆#177;23.15, 37.73＆#177;24.64, 10.18＆#177;5.71, 170.43＆#177;61.74 and 68.02＆#177;25.14. The value of P＆gt;0.05 in all items. All of the eight biochemistry test results are highly relevant with each other between the biochemistry analysis module and OLYMPUS AU5421 automatic biochemical analyzer. The results of GLU,UA and ALB were not significantly different（P＆gt;0.05）, but the difference was significant in that of CREA, ALT, TBIL, LDH and AMS（P＆lt;0.01）. Conclusion：In indoor or simulated field environment, biochemical analysis module of Biochem POCT Solutions has good precision, and the results have no significant difference between two environments. The results of the biochemistry analysis module and OLYMPUS AU5421 automatic biochemical analyzer correlated well. Due to the different detection methods, some results quite different, but still comparable.

关 键 词：战地快速检验方法 医学检验装备 野战 全自动生化分析仪 

分 类 号：R446.1[医药卫生—诊断学]